Safety and Efficacy of Oral BT-11 in Crohn's Disease Patients With Moderate to Severe Disease

Inclusion Criteria

• •1. Male and female subjects age 18 to 75 years, inclusive.
• •2. Diagnosis of CD for at least 6 weeks prior to screening
• •3. Moderate to severely active CD as defined by all of the following:
• •* CDAI score of 220-450
• •* PRO-2 stool frequency (SF) ≥ 4 and/or abdominal pain (AP) ≥ 2
• •* SES-CD ≥ 6 ( ≥4 for isolated ileitis) scored by a blinded central reader